The Effect of Nature-based Exposure on the Immune System and Skin Health of Atopic Dermatitis Patients.

The purpose of the study is to explore the effect of nature-based exposure on immunological biomarkers and the condition and symptoms of atopic skin. Our hypothesis is that regular exposure to nature-based, high biodiversity material on skin, strengthens the skin's protective barrier and has a positive effect on the immunological biomarkers associated with atopic dermatitis. Further our hypothesis is that the difference between the groups (active and placebo) is noticeable during winter time when the disease is typically worse because of the cold weather. The study aim at scientific publication and is double-blinded and placebo-controlled. Time of the intervention is 6-7 months: intervention starts before the Finnish winter time and ends before the summer.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Nature-based exposure by biodiversity component in lotion.; Other: Placebo group using colored lotion.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00290
    • Uute Scientific Oy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• A person aged 18-65, legally competent
• Meets Hanifin & Rajka's criteria for atopic dermatitis in the initial interview and eczema has also appeared regularly in adulthood
• The possibility to commit to the research

Exclusion Criteria:

• Cancer or cancer treatments
• Medication that suppresses the immune system (excluding antihistamines)
• Systemic medicine intended for the treatment of atopic dermatitis (orally or as an injection, other than an antihistamine) or the use of clinical phototherapy in the last 6 months.
• Skin infection (such as a eczema that required antibiotic cream or a parasitic infection, e.g.scabies mite) during the last 6 months
• Atopic dermatitis that required hospitalization in the last 2 years
• Psoriasis or other skin disease affecting the study in addition to atopy
• Pregnancy or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nature-based exposure by biodiversity component in lotion.; This group uses regularly the lotion with added natural biodiversity component. The component is mimicking natural exposure to Finnish forest soil and it contains high microbial diversity. The microbes are inactivated.	Other: Nature-based exposure by biodiversity component in lotion.; Lotion is used at minimum three times per week and at least to arms. No restrictions to normal life and self-care. Atopy medicines and lotions are allowed when needed, only the usage amount is followed.
Placebo Comparator: Placebo group using colored lotion.; This group uses regularly the same vehicle lotion than Nature exposure group, with the difference that the biodiversity component has been replaced with safe coloring ingredients to give the same brownish color than in the other group's lotion. Coloring ingredients are iron oxides that are common in foods and cosmetics: C.I.7791, C.I.77492, C.I. 774499.	Other: Placebo group using colored lotion.; Lotion is used at minimum three times per week and at least to arms. No restrictions to normal life and self-care. Atopy medicines and lotions are allowed when needed, only the usage amount is followed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transepidermal water loss (TEWL)	Transepidermal water loss level at designated places	4 or 7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POEM (Patient Oriented Eczema Measure)	POEM points during the study	Assessment is done every two weeks by the participant
Need of atopy medicines	Number of medicine free days	4 or 7 months
EASI (Eczema Area and Severity Index)	EASI score	4 or 7 months
Erythema index	Erythema index at designated places	4 or 7 months
Skin pH value	Skin pH value of designated places	4 or 7 months
Immunological markers in saliva, skin and blood samples	Immunological markers, like cytokines, in saliva, skin and blood samples and their expression analyzed from RNA.	4 or 7 months
Adverse events	Adverse events during the trial	Assessment is done every two weeks by the participant
NRS itch	NRS itch score during the trial	Assessment is done every two weeks by the participant

Collaborators and Investigators

• Sponsor: Uute Scientific Oy
• Collaborators: Tampere University
• Investigators: Principal Investigator: Olli Laitinen, PhD, Uute Scientific and Tampere University

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Actual): June 17, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Allergy; Atopy; Biodiversity intervention; Environmental microbes
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: Uuteatopia2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No